AstraZeneca's Tezspire Gets FDA Nod for CRSwNP: A Game-Changer in Respiratory Therapeutics

AstraZeneca and Amgen's Tezspire (tezepelumab-ekko) has secured a landmark U.S. Food and Drug Administration (FDA) approval on October 17, 2025, for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in patients aged 12 and older, according to a PR Newswire release. This approval marks the first biologic targeting thymic stromal lymphopoietin (TSLP), a key cytokine in epithelial-driven inflammation, to address this complex condition. With the global CRSwNP biologics market projected to grow at a compound annual growth rate (CAGR) of 7% from $3.5 billion in 2025 to $9 billion by 2033, according to a Data Insights forecast, Tezspire's entry into this space positions it as a transformative player in respiratory therapeutics.

Tezspire's approval for CRSwNP expands its existing indication for severe asthma, leveraging its upstream mechanism of action against TSLP—a cytokine central to multiple inflammatory pathways. Clinical trials, including the Phase III WAYPOINT study, demonstrated statistically significant reductions in nasal polyp severity, a near-elimination of surgical interventions, and an 88% decrease in systemic corticosteroid use compared to placebo. These outcomes underscore its potential to address a high unmet need, as patients with CRSwNP often require repeated surgeries and corticosteroid therapies with limited long-term efficacy.

Analysts project Tezspire could achieve $3.6 billion in sales by 2030, per The Business Research Company forecast, capitalizing on its demonstrated efficacy in reducing disease burden and healthcare costs. Regulatory submissions in Europe, China, and Japan further amplify its global growth potential, with the Asia-Pacific region expected to see robust expansion due to rising healthcare spending and disease prevalence.

Long-Term Strategic Implications

Tezspire's approval for CRSwNP is not merely an incremental advance but a strategic pivot for AstraZeneca and Amgen. By addressing a second epithelial-driven condition, the drug reinforces its role in a broader inflammatory disease portfolio, including potential expansions into COPD and eosinophilic esophagitis (EoE), as discussed in an Archyde article. This diversification mitigates reliance on asthma-specific markets and aligns with the industry's shift toward upstream biologics.

For investors, Tezspire's success hinges on its ability to secure rapid adoption among otolaryngologists and allergists, a process likely accelerated by its favorable safety profile (consistent with its asthma use) and the absence of new safety signals in the WAYPOINT trial. However, challenges such as high drug costs and payer resistance to biologics remain.

Conclusion

AstraZeneca's Tezspire represents a paradigm shift in CRSwNP treatment, offering a novel mechanism with proven clinical and economic benefits. With a $3.6 billion revenue forecast by 2030 and a growing global market, Tezspire is poised to redefine the biologics landscape for respiratory diseases. For investors, this approval signals a high-conviction opportunity in a sector primed for innovation and long-term growth.